nighttime cold and flu multi symptom

Generic: acetaminophen dextromethorphan hydrobromide doxylamine succinate

Labeler: cardinal health 110, llc. dba leader 70000
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name nighttime cold and flu multi symptom
Generic Name acetaminophen dextromethorphan hydrobromide doxylamine succinate
Labeler cardinal health 110, llc. dba leader 70000
Dosage Form CAPSULE, LIQUID FILLED
Routes
ORAL
Active Ingredients

acetaminophen 325 mg/1, dextromethorphan hydrobromide 15 mg/1, doxylamine succinate 6.25 mg/1

Manufacturer
CARDINAL HEALTH 110, LLC. DBA LEADER 70000

Identifiers & Regulatory

Product NDC 70000-0516
Product ID 70000-0516_5356fa4b-1290-4283-b0f0-3039c65d2515
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2027-12-31
Marketing Start 2019-08-30

Pharmacologic Class

Classes
antihistamine [epc] histamine receptor antagonists [moa] sigma-1 agonist [epc] sigma-1 receptor agonists [moa] uncompetitive n-methyl-d-aspartate receptor antagonist [epc] uncompetitive nmda receptor antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 700000516
Hyphenated Format 70000-0516

Supplemental Identifiers

RxCUI
1094549
UPC
0096295138337
UNII
362O9ITL9D 9D2RTI9KYH V9BI9B5YI2

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name nighttime cold and flu multi symptom (source: ndc)
Generic Name acetaminophen dextromethorphan hydrobromide doxylamine succinate (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 325 mg/1
  • 15 mg/1
  • 6.25 mg/1
source: ndc
Packaging
  • 16 BLISTER PACK in 1 CARTON (70000-0516-1) / 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
  • 24 BLISTER PACK in 1 CARTON (70000-0516-2) / 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
source: ndc

Packages (2)

70000-0516-1 16 BLISTER PACK in 1 CARTON (70000-0516-1) / 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK 70000-0516-2 24 BLISTER PACK in 1 CARTON (70000-0516-2) / 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK

Ingredients (3)

acetaminophen (325 mg/1) dextromethorphan hydrobromide (15 mg/1) doxylamine succinate (6.25 mg/1)

Linked Drug Pages (1)

NightTime Cold and Flu Multi Symptom ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "5356fa4b-1290-4283-b0f0-3039c65d2515", "openfda": {"upc": ["0096295138337"], "unii": ["362O9ITL9D", "9D2RTI9KYH", "V9BI9B5YI2"], "rxcui": ["1094549"], "spl_set_id": ["a8460fc9-2d08-4e5f-8dd3-5135ecda5923"], "manufacturer_name": ["CARDINAL HEALTH 110, LLC. DBA LEADER 70000"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "16 BLISTER PACK in 1 CARTON (70000-0516-1)  / 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK", "package_ndc": "70000-0516-1", "marketing_start_date": "20190830"}, {"sample": false, "description": "24 BLISTER PACK in 1 CARTON (70000-0516-2)  / 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK", "package_ndc": "70000-0516-2", "marketing_start_date": "20190830"}], "brand_name": "NightTime Cold and Flu Multi Symptom", "product_id": "70000-0516_5356fa4b-1290-4283-b0f0-3039c65d2515", "dosage_form": "CAPSULE, LIQUID FILLED", "pharm_class": ["Antihistamine [EPC]", "Histamine Receptor Antagonists [MoA]", "Sigma-1 Agonist [EPC]", "Sigma-1 Receptor Agonists [MoA]", "Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC]", "Uncompetitive NMDA Receptor Antagonists [MoA]"], "product_ndc": "70000-0516", "generic_name": "ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE DOXYLAMINE SUCCINATE", "labeler_name": "CARDINAL HEALTH 110, LLC. DBA LEADER 70000", "product_type": "HUMAN OTC DRUG", "brand_name_base": "NightTime Cold and Flu", "brand_name_suffix": "Multi Symptom", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "325 mg/1"}, {"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "15 mg/1"}, {"name": "DOXYLAMINE SUCCINATE", "strength": "6.25 mg/1"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20190830", "listing_expiration_date": "20271231"}